Current Status of PANDRH Bioequivalence Working Group

12/2/2009 DIA 2nd Latin American Regulatory Conference Mexico City November 18-20, 2009 Current Status of PANDRH Bioequivalence Working Group Justin...
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12/2/2009

DIA 2nd Latin American Regulatory Conference Mexico City November 18-20, 2009

Current Status of PANDRH Bioequivalence Working Group Justina A. Molzon, MS Pharm, JD Associate Director for International Programs Center for Drug Evaluation and Research US Food and Drug Administration The views expressed in this presentation are those of the author and do not necessarily represent the views of the U.S. Food and Drug Administration

Pan American Network for Drug Regulatory Harmonization Buenos Aires, Argentina 17–19 November 2008

• V Conference of the Pan American Network for Drug Regulatory Harmonization (PANDRH) • Information and propositions of 9 working g groups g p presented p for consideration

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PANDRH V Conference Working Group Reports 1. Bioequivalence and Bioavailability 1 2. Vaccines 3. Medicines Promotion 4. Pharmacovigilance 5. Drug Counterfeiting 6. Good Manufacturing Practices 7. Good Laboratory Practices 8. Good Clinical Practices 9. Registration Requirements

Bioequivalence and Bioavailability Working g Group p

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PANDRH Steering Committee Priorities Urgent Issues: • GMP (FDA) • BA/BE (FDA) • GCP (ANMAT) • Counterfeit (ANVISA)

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Proposals • The Conference adopt the document: Framework for Implementation of Equivalence Requirements for Pharmaceutical Products • The conference recommend training to promote implementation by the NDRA – On the document – On bioequivalence and statistics

• The Conference recommend the development of indicators to evaluate implementation of BE in the Americas

Topics Discussed • • • •

Training required Need for case studies Need to establish BE centers Decision tree for prioritizing need to implement BE studdies • Experience in implementing BE studies • Need for DRA to link local innovator to product establishing safety and efficacy

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Bioequivalence Centers • Establish regional BE centers to perform studies t di ffor countries ti – Recognized, established, validated

• Established and supported by private sector

Decision Tree • • • •

Questions on key decision points Decision tree modified to clarify concerns Satisfactory results=Meet f2 requirements If not met= case by case DRA decision

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2006 WHO Guidelines Related to Bioequivalence Studies • 40th report of the WHO Expert Committee on Specifications p for Pharmaceutical Preparations. p Geneva, World Health Organization. • WHO Technical Report Series, No. 937, 2006: – Multisource (generic) pharmaceutical products: guidelines on registration requirements to establish interchangeability. Annex 7. – Proposal to waive in vivo bioequivalence requirements for the WHO Model List of Essential Medicines immediate release, solid oral dosage forms. Annex 8. – Additional guidance for organizations performing in vivo bioequivalence studies. Annex 9.

WHO Report 36 Annex 11 • Important to include reference to WHO G id Guidance on th the selection l ti off comparator t pharmaceutical products for equivalence assessment of interchangeable multisource (generic) products. WHO Expert Committee on Specifications for Pharmaceutical Preparations, Annex 11, page161-180, WHO Technical Report Series 902,2002

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WHO Guidelines Related to Bioequivalence Studies • Update to Annex 11 anticipated • Document should be linked to updated WHO guidelines on relevant topics • Always use most current WHO guidelines generally g y linked to WHO Prequalification q Program • Include updates in text and decision trees

Training Suggested • Document – DRA=Evaluation and inspection – Industry=Application and use

• Principles of BA/BE – FDA modules concepts

• BCS • Statistics in BE study evaluation • Case studies

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Develop Case Studies • To assist DRA and industry in i l implementation t ti and d application li ti off th the document • Selection of reference product – Link generic to reference product demonstrating g safety y and efficacy y – Promote discussion on implementation of requirement of linking local innovator with original product according to methodology of document

Education on Strategies and Technical Information • To inform the public, industry and DRA about the need for and implication of BE studies and tests as registration requirements for some API and dosage forms • Education programs focused on confidence building in generic drugs for the public and health care professionals

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Capture Experience • Annex 2 details experience in country – Chile, Costa Rica, Venezuela, Argentina

• Several countries asked to be included – Panama, Uraguay

• Important to capture and update Annex with implementation experience as countries implement BE studies • Send information to Nelly Marin PAHO – [email protected]

Discussion • During g the implementation p p process PAHO should establish a mailbox for questions related to implementation of the Framework • Questions answered by WG members and posted on PAHO web • Will h help l monitor it iimplementation l t ti process

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